Synthes (USA) Products LLC Recall 93924
Description: RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. Part Number: 530.553.01S
Synthes (USA) Products LLC Recall 93924 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1238-2024 |
Event ID | 93924 |
Event Description | RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. Part Number: 530.553.01S |
Product Type | Devices |
Distribution | Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa. |
Quantity | 10 units |
Recall Reason | Products not sterilized, sterility cannot be confirmed |
Device Classification | 20240313 |
Device Code Info | UDI: 10887587057262 Lot Number: 499P371 |
Center Classification Date | 20240301 |
Recall Initiation Date | 20240124 |
Recalling Firm | Synthes (USA) Products LLC |
Initial Notification | |
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